MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number 5950090

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 06/15/2020

Event Type  Injury  

Event Description

Per symposium presentation during (b)(6) - "three cases of mesh infection after abdominal wall hernia requiring mesh removal" as reported, the patient underwent repair of a ventral incisional hernia and a bard/davol ventrio st mesh was implanted.It was reported that mesh infection occurred approximately 4 months after the operation.Wound opening and conservative treatment of vac therapy did not improve, and one month later, mesh removal and direct suturing were performed.It was also reported that the patient was doing well and discharged 10 days after the operation.

Manufacturer Narrative

Based on the information obtained, no conclusion can be made.Postoperative infection is a known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." without a lot number, review of the manufacturing records cannot be conducted.Note, the date of event is estimated based on the information available.If/when additional information be provided, a supplemental emdr will be submitted.Not returned - mesh explanted.

• Brand Name: VENTRIO ST
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12822216
• MDR Text Key: 283310854
• Report Number: 1213643-2021-20412
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5950090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male